Effects of ivabradine in patients with stable coronary artery disease without heart failure.

• Register: EUCTR
• Last refreshed on: 11 August 2014
• Main ID: EUCTR2009-011360-10-BE
• Date of registration: 18/09/2009
• Prospective Registration: Yes
• Primary sponsor: Institut de Recherches Internationales Servier
• Public title: Effects of ivabradine in patients with stable coronary artery disease without heart failure.
• Scientific title: Effects of ivabradine in patients with stable coronary artery disease without clinical heart failure. A randomised double-blind placebo-controlled international multicentre study. - SIGNIFY
• Date of first enrolment: 07/12/2009
• Target sample size: 16850
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-011360-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Argentina, Armenia, Australia, Austria, Belgium, Bulgaria, Canada, China, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Kazakhstan, Korea, Democratic People's Republic of, Latvia, Lithuania, Macedonia, the former Yugoslav Republic of, Malaysia, Mexico, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, Vietnam

Contacts

• Name: Clinical Studies Department
• Affiliation: Institut de Recherches Internationales Servier

• Name: Clinical Studies Department
• Affiliation: Institut de Recherches Internationales Servier

Key inclusion & exclusion criteria

Inclusion criteria:
- Aged 55 years or older,
- Male or female,
- Patients with stable coronary artery disease without clinical heart failure,
- Sinus rhythm and resting heart rate equal or higher than 70 bpm.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8900
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7950

Exclusion criteria:
- Unstable cardiovascular condition,
- Contra-indications to the administration of ivabradine or current treatment with marketed ivabradine.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Coronary artery disease
MedDRA version: 16.0 Level: PT Classification code 10011078 Term: Coronary artery disease System Organ Class: 10007541 - Cardiac disorders

Intervention(s)

Trade Name: PROCORALAN
Product Name: S16257
Product Code: S16257
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ivabradine
CAS Number: 155974-00-8
Current Sponsor code: S16257-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: PROCORALAN
Product Name: S16257
Product Code: S16257
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ivabradine
CAS Number: 155974-00-8
Current Sponsor code: S16257-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7.5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: S16257
Product Code: S16257
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ivabradine
CAS Number: 155974-00-8
Current Sponsor code: S16257-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To evaluate the effect of ivabradine on cardiovascular events in patients with coronary artery disease.

Secondary Objective: Efficacy and safety.

Primary end point(s): Composite endpoint made of cardiovascular mortality or non fatal myocardial infarction.

Timepoint(s) of evaluation of this end point: Composite endpoint measured up to 42 months

Secondary Outcome(s)

Secondary end point(s): Efficacy and safety endpoints

Timepoint(s) of evaluation of this end point: Efficacy and safety endpoints measured up to 42 months

Secondary ID(s)

ISRCTN61576291

CL3-16257-083

2009-011360-10-ES

Source(s) of Monetary Support

ADIR